Will the FDA Approve a Vaccine in September?

Will the FDA Approve a Vaccine in September?
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The US will have four coronavirus candidate vaccines in clinical trials by September. This is a fantastic thing since we’ve all seen how the timeline of the virus has amazed us all. It all started in December, and here we are now, with a possible vaccine in works.

 

The government is very pleased with this progress. The deputy chief of staff of Health and Human Services, Paul Mango, is the liaison of the agency with Operation Warp Speed. We are talking about the White-House task force assigned to the coronavirus and the development of a treatment. Mango stated: “We feel we are absolutely on track β€” if not a little bit ahead β€” in terms of our overall objective, which is tens of millions of (doses of) safe and effective vaccines approved for calendar year-end.”

 

About the clinical trials

 

We learned that each Phase 3 of the clinical trials would have 30.000 volunteers. There are two that are halfway there. Every detail and the data about the vaccines show that they are causing the bodies of the volunteers to produce a huge amount of neutralizing antibodies. However, this does not mean that a vaccine candidate will be protected against the COVID-19 virus, but there is a chance.

In the beginning, there will be a limited number of doses to give to the patients. There will be certain groups that will get the vaccine first, like healthcare workers and elderly people.

 

Dr. Robert Redfield, director of the Centers for Disease Control and Prevention, stated: “We want to be prepared for whichever vaccine makes it through the gate.” Companies have already started making three of the six candidate vaccines that Operation Warp Speed has funded. Redfield also said: “For the other three, we are retrofitting a number of facilities, we are receiving equipment from all over the world, and those will start shortly as well.”

 

Currently, the government is working on how to distribute the vaccines, which will eventually get approved. Five out of these six vaccines need two doses – 21 days apart and 28 days apart.


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